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Sponsored by: |
Zogenix, Inc. |
---|---|
Information provided by: | Zogenix, Inc. |
ClinicalTrials.gov Identifier: | NCT00614029 |
A study to evaluate the pharmacokinetics and bioequivalence of sumatriptan delivered by the Intraject system.
Condition | Intervention | Phase |
---|---|---|
Pharmacokinetics Bioequivalence |
Device: Sumatriptan (via Intraject System) |
Phase I |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study |
Official Title: | A Randomized, Open-Label, Single-Dose, Four-Way Crossover Study to Evaluate the Pharmacokinetics and Bioequivalence of Sumatriptan Delivered Via the Intraject System Versus IMITREX STATdose at Three Injection Sites in Healthy Adults |
Enrollment: | 54 |
Study Start Date: | December 2006 |
Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
IMITREX -abd. to Intraject-abd. to IMITREX -thigh to Intraject-thigh
|
Device: Sumatriptan (via Intraject System)
0.5 mL of solution with 6 mg of sumatriptan (base) as the succinate salt
|
B: Experimental
Intraject-abd. to IMITREX -abd. to Intraject-thigh to IMITREX -thigh
|
Device: Sumatriptan (via Intraject System)
0.5 mL of solution with 6 mg of sumatriptan (base) as the succinate salt
|
C: Experimental
Intraject-abd to IMITREX -abd to Intraject-arm. to IMITREX -arm.
|
Device: Sumatriptan (via Intraject System)
0.5 mL of solution with 6 mg of sumatriptan (base) as the succinate salt
|
D: Experimental
IMITREX-abd to Intraject-abd to IMITREX-arm. to Intraject-arm.
|
Device: Sumatriptan (via Intraject System)
0.5 mL of solution with 6 mg of sumatriptan (base) as the succinate salt
|
E: Experimental
IMITREX-arm to Intraject-arm to IMITREX-thigh to Intraject-thigh
|
Device: Sumatriptan (via Intraject System)
0.5 mL of solution with 6 mg of sumatriptan (base) as the succinate salt
|
F: Experimental
Intraject-thigh to IMITREX-thigh to Intraject-arm to IMITREX-arm
|
Device: Sumatriptan (via Intraject System)
0.5 mL of solution with 6 mg of sumatriptan (base) as the succinate salt
|
A single center, randomized, single-dose, open-label, partial-block, four-period, four-way crossover study in 54 healthy adult subjects to evaluate the pharmacokinetics and bioequivalence of sumatriptan delivered by the Intraject system compared to IMITREX STATdose at three injection sites (abdomen, thigh, and arm.)
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Zogenix, Inc ( Stephen J. Farr, Ph.D/ President and COO ) |
Study ID Numbers: | ZX001-0601 |
Study First Received: | January 7, 2008 |
Last Updated: | February 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00614029 |
Health Authority: | United States: Food and Drug Administration |
sumatriptan Injections Subcutaneous |
Sumatriptan Naphazoline Oxymetazoline Guaifenesin |
Phenylephrine Phenylpropanolamine Healthy Serotonin |
Serotonin Agonists Neurotransmitter Agents Serotonin Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Physiological Effects of Drugs Vasoconstrictor Agents Cardiovascular Agents Pharmacologic Actions |